Disinfectant Delivery System and Method of Providing Alcohol-Free Disinfection

ABSTRACT

A disinfectant delivery system and method of providing alcohol-free disinfection to a body to be disinfected, as well as a method of infection reduction by preparation of a patient before an invasive procedure. A blended cloth comprising first fibers and second fibers is provided with the first fibers generally being greater in quantity by weight than the second fibers. A disinfectant solution impregnates the blended cloth, with the disinfectant solution having chlorhexidine gluconate as an active ingredient and having no alcohol. In the method according to the invention, at least one impregnated blended cloth is used to disinfect at least a portion of a body. A plurality of blended cloths can be provided for disinfecting discrete portions of the body. When an invasive procedure is to be performed on a patient, a further method according to the invention of infection reduction comprises using a CHG-impregnated cloth to disinfect at least a portion of the patient at least one day prior to the invasive procedure proximate the location of the invasive procedure.

RELATED APPLICATION

This application is a continuation of copending U.S. patent applicationSer. No. 10/435,902, filed May 12, 2003.

BACKGROUND OF THE INVENTION

This invention relates to disinfection and in particular to adisinfectant delivery system and a method of providing alcohol-freedisinfection to a body to be disinfected. The invention also relates toa method of infection reduction by preparation of a patient before aninvasive procedure.

Resistant organisms, such as MRSA and VRE, are an increasing problem inmodern health care facilities. Once a patient becomes colonized andacquires an infection from a resistant organism, it is difficult andcostly to treat the infection. The result has been a significantincrease in morbidity and mortality for health care facilities.

Previously, it has been known to provide a patient bathing system havingwashcloths for body cleansing. U.S. Pat. Nos. D 394,605; 5,725,311;5,906,278; 5,956,794 and 6,029,809, all assigned to the assignee of thepresent application, are directed to such a system. A resealable packageis provided having a plurality of washcloths contained therewithin. Thepackage has an opening through which washcloths can be individuallywithdrawn for body cleansing. The package can be heated, such as in amicrowave or other heating facility, so that withdrawn washcloths arecomfortable to the patient when used.

Such a system and washcloths are convenient and effective for bodycleansing. However, until the present invention, microbial disinfectionhas not been possible with such a system.

Chlorhexidine gluconate (CHG) is a highly effective broad-spectrumtopical antiseptic. It is effective against both gram-positive andgram-negative bacteria. In addition, CHG exhibits the property ofpersistence in that it continues its anti-microbial activity beyondimmediate bacteria elimination, providing protection several hoursbeyond an initial application.

Moreover, CHG exhibits a cumulative property that improves efficacyafter multiple applications. Finally, CHG is well-tolerated on humanskin. It is currently considered to be the premiere topical antisepticingredient by the health care community.

Pre-surgical or skin puncture preparation requires delivery of anantiseptic to the body area being prepared for an invasive procedure.CHG has been used in the past in pre-surgical preparations, althougheach such preparation employs alcohol as an active ingredient. Never hasCHG been used alone as the active ingredient of a pre-surgicalpreparation, nor has CHG of any nature ever been delivered via apre-impregnated disposable washcloth.

When skin bacteria is to be reduced, a pre-surgical preparation isapplied to the patient's skin immediately before the surgical procedure.One method also attempted in the past, but not in widespread use, is toapply topical antiseptics to the entire body several days prior to thesurgical procedure, which, in theory, reduces skin bacteria levels evenbefore a pre-surgical preparation is applied. The combination seems tofurther reduce post-surgical infection.

SUMMARY OF THE INVENTION

In one form, the invention is directed to a disinfectant deliverysystem, which comprises a blended cloth comprising first fibers andsecond fibers. The quantity by weight of the first fibers is generallygreater than the quantity by weight of the second fibers, and theabsorbency by weight is greater than weight of the blended cloth. Adisinfectant solution impregnates the blended cloth with thedisinfectant solution having chlorhexidine gluconate as an activeingredient and having no alcohol.

In accordance with the preferred form of the invention, the fibers areblended by entanglement, and comprise polyester. Preferably, the firstfibers have one thickness and the second fibers have a thickness that isdifferent than the one thickness. In the disclosed embodiment of theinvention, the first thickness is about 1.2 to 1.5 denier. The secondthickness is about 4.75 denier. In all forms of the invention, thefibers have a length of from about 1.5 to 3 inches.

The CHG is present in about 1.80 to 2.20 percent by weight of thedisinfecting solution. Preferably the CHG is 2 percent by weight, but ithas been found effective in the range just explained.

In the method according to the invention, the blended cloth is provided,as well as a disinfecting solution having chlorhexidine gluconate as anactive ingredient with no alcohol.

The cloth is impregnated with the disinfecting solution, and theimpregnated cloth is then used to disinfect at least a portion of abody.

In another preferred form of the invention, a plurality of the blendedcloths are provided, all of which are impregnated by the disinfectingsolution. Then, when used, each of the impregnated cloths is used todisinfect a discrete portion of the body. The cloths can be providedpackaged in a resealable package before use, or can be impregnatedimmediately prior to use.

In yet another form of the invention, infection reduction isaccomplished by preparation of a patient before an invasive procedure. Ablended cloth is provided, comprising a fibrous mat which is impregnatedwith the disinfecting solution having chlorhexidine gluconate as anactive ingredient and having no alcohol. The impregnated cloth is thenused to disinfect at least a portion of the patient at least one dayprior to the invasive procedure proximate the location of the invasiveprocedure.

Preferably, the blended cloth according to the invention is used as thefibrous mat, and a plurality of cloths are provided in a package, sothat each cloth can be used to disinfect a discrete portion of thepatient at least one day prior to the invasive procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in greater detail in the followingdescription of examples embodying the best mode of the invention, takenin conjunction with the drawing figures, in which:

FIG. 1 is a top plan view of one form of a disinfectant delivery systemaccording to the invention;

FIG. 2 is a side elevational view thereof,

FIG. 3 is an end elevational view thereof,

FIG. 4 is a cross-sectional view thereof, taken along lines 4-4 of FIG.1, and

FIG. 5 is an elevational view of one of the blended cloths according tothe invention, shown surrounded by phantom lines in FIG. 4.

DESCRIPTION OF EXAMPLES EMBODYING THE BEST MODE OF THE INVENTION

A disinfectant delivery system having blended cloths according to theinvention is shown generally at 10 in the drawing figures. The system 10includes three components, a sealed, hollow, flexible outer package 12,an insulating and supporting layer 14, and a plurality of blended cloths16.

U.S. Pat. Nos. 5,275,311; 5,906,278; 5,956,794 and 6,029,809, thedisclosures of which are incorporated herein by reference, illustrateearlier forms of structures similar to those of the present application,when used in connection with a patient bathing system. As explained inthe incorporated patents, the outer package 12 is preferably formed fromthin, plastic film in an elongated fashion having a generallyrectangular cross section as shown in FIG. 4. A package has end heatseals 18 and a longitudinal heat seal 20. The package 12 may beconventional.

The outer package 12 also includes an elongated dispensing slit 22. Itmay be sealed in many conventional fashions, and in one form, a seal inthe form of a label 24 is applied to the outer package over the slit 22.The label 24 can be conventional or as described in incorporated U.S.Pat. No. 5,725,311. The label 24 also includes a free end 26 which isfree to be grasped by a user for peeling the label 24 to expose the slit22.

The insulating and supporting layer 14 is depicted in FIG. 4. Itpreferably comprises a foam sheet which has been shaped to conform tothe interior of the outer package 12. For shaping purposes, a series oflateral slits 28 are formed in the foam sheet in general registrationwith the corners of the outer package 12, as explained in incorporatedU.S. Pat. No. 5,906,278.

The insulating layer 14 terminates at opposite ends 30 and 32. The endedges 30 and 32 are disposed on opposite sides of the elongateddispensing slit 22 to permit access to the interior of the package 12,if the insulated layer 14 is utilized. In instances where heating of theinterior of the outer package 12 is unnecessary, or where maintenance oftemperature after heating is not needed, the insulating layer 14 may beeliminated.

The blended cloths 16 are individual, folded structures which arestacked one atop the other for individual dispensing through thedispensing slit 22. The cloths 16 are absorbent and are impregnated witha disinfectant solution. The cloths 16 have a sufficient porosity tohold a desired amount of the disinfectant solution, which is uniformlydispersed as explained below.

Each of the cloths 16 comprises a blended cloth comprising first fibersand second fibers, with the quantity by weight of the first fibers beinggenerally greater than the quantity by weight of the second fibers. Theblended cloth 16 has an absorbency by weight much greater than theweight of the blended cloth. Preferably, the fibers of the blended cloth16 are polyester. The first fibers have one thickness and the secondfibers have a second thickness that is different from that of the firstfibers. In accordance with the preferred form of the invention, thethickness of the first fibers is about 1.2 to 1.5 denier. The thicknessof the second fibers is greater, at about 4.75 denier. All of the fibershave a length from about 1.5 to 3 inches. In a particularly preferredform of the invention, the first fibers constitute 70 percent of theblend by weight, while the second fibers constitute 30 percent of theblend by weight. The cloth 16 is densely blended and has an absorbencyof water much greater by weight than the weight of the blended cloth,with the absorbency being at least eight times by weight, and preferablyover ten times by weight.

The fibers are generally round in cross-section, and when mechanicallyentangled together have a tensile strength of 20 pounds per inch, orgreater. The fibers, when concentrated by mechanical entanglement, havea density of about 4.3 ounces per square yard to about 5.3 ounces persquare yard for a cloth having an average thickness of 0.090 inches. Thepreferred concentration for an optimal cloth of this thickness is about4.8 ounces per square yard.

The blended cloths 16 can have a thickness from about 0.055 inches to0.125 inches, with the preferred thickness being about 0.090 inches.Other thicknesses can be employed so long as the absorbency andconcentration of the fibers are within the parameters set forth herein.

The disinfectant solution utilizes chlorhexidine gluconate (CHG) as theactive ingredient. CHG has been employed for several reasons. First, CHGis a highly effective broad-spectrum topical antiseptic that has beenshown to be effective against both gram-positive and gram-negativebacteria. Second, CHG exhibits the property of persistence. It continuesits anti-microbial activity beyond the immediate purge of the treatedarea, providing protection for hours beyond initial application. Third,CHG exhibits a cumulative property that improves efficacy after multipleapplications. Fourth, CHG is well-tolerated on human skin. Otherequivalent disinfectant solutions can be employed, but such solutionsmust exhibit the four qualities just mentioned.

In addition, CHG has an affinity for certain types of fibers, and thepolyester structure of the blended cloth 16 has been tested to releaseall of the CHG when used. The CHG solution is alcohol-free, in that noalcohol of any nature is employed, unlike all previous solutions usingCHG, which have always had alcohol as an active and major ingredient. Itis thought that the combination of the unique blend of fibers and CHGleads to the superior combination according to the invention.

One disinfectant solution according to the invention comprises 2 percentCHG with a water base. In percent by weight, in such an example, waterconstitutes 73.25 percent, and a 20 percent CHG solution comprises 10.90percent. Two other ingredients are available in significant percents,propylene glycol at 3.10 percent and glycerin at 2.50 percent. Otherminor ingredients, including aloe vera, dimethicon 350 cst, igepal CO630, polysorbate 20, shaw mudge fragrance and glucono delta lactoneconstitute, in the aggregate, less than 1 percent. In preparing thesolution, 13.25 percent water by weight is retained, and all remainingingredients except for the 20 percent CHG are mixed. Then, the 20percent solution of CHG and the final 13.25 percent water are added, andthe entire solution is mixed to form the disinfectant solution accordingto the invention. Finally, the disinfectant solution is used toimpregnate the blended cloths 16. The disinfectant solution is evenlydispersed throughout each of the blended cloths 16 in either packagedform, as shown in the drawing figures, or the disinfectant solution canbe added to dry cloths 16 at a later time. The preferred delivery systemis a package as shown in the drawing figures containing at least one ofthe blended cloths 16.

The invention can uniquely be used to provide infection reduction bypreparation of a patient before an invasive procedure, such as surgery,introduction of a catheter, or any procedure that is intended to piercethe skin in any manner. Any such procedure will be termed herein assurgical site preparation, and it has been found that surgical siteinfections can be greatly reduced by utilizing the invention at leastone day prior to the invasive procedure. The standard method of reducingskin bacteria is to use a pre-surgical preparation on patient's skinimmediately before the surgical procedure. The invention of the presentapplication can be used at least one day, and even more, before thesurgical procedure, which cumulatively reduces skin bacteria levels evenbefore pre-surgical preparation occurs immediately prior to surgery or asimilar invasive procedure. This combination further reduces thepost-surgical infection rate beyond a simple standard pre-surgicalpreparation.

The method according to the invention is unique in that the disinfectingsolution having CHG is applied as a “no-rinse” solution without a showeror bath to dilute the ingredients, and it can be applied in the vicinityof the future invasive procedure, or over the entire body. Preferably,the blended cloths having the CHG disinfecting solution are appliedsequentially to all body parts to lower the total skin bacteria count onthe body about a day or more in advance of the invasive procedure. Then,at the time of the invasive procedure, standard preparation of thepatient's skin is performed in the normal manner.

Achievements

The invention provides a unique, no-rinse disinfectant delivery systemcomprising blended cloths 16 impregnated with a disinfectant solutionhaving only CHG as the active ingredient, without alcohol. In the past,CHG has been used as a topical disinfectant, but always with alcohol,and never in a combination comprising a pre-impregnated disposablewashcloth.

By using the system according to the invention for full-bodydisinfection (such as with one cloth for each of the arms, one cloth foreach of the legs, a cloth for the trunk, and a cloth for the perineumand buttocks), the cycle of skin colonization with resistant organismsis broken, reducing the spread of organisms to the environment and tothe health care workers. This greatly reduces the risk of spreadingresistant organisms throughout a health care facility.

The risk of infection is reduced by the invention when a patient isprepared a day, and sometimes days, in advance of an invasive procedure.With the CHG-containing disinfectant solution applied sequentially toall body parts, the total skin bacteria count is reduced, and withnormal preparation before an invasive procedure, the post-surgicalinfection rate experienced by patients is reduced beyond that ofstandard preparation of a patient immediately prior to an invasiveprocedure.

The blended cloth 16, comprising a unique blend of all polyester fibers,permits delivery of the disinfectant solution to the area being treated.Tests have shown that all of the CHG is released from the blended cloths16 when used for body disinfection.

Various changes can be made to the invention without departing from thespirit thereof or scope of the following claims.

1-10. (canceled)
 11. A method of infection reduction by preparation of apatient before an invasive procedure, comprising a. providing a firstblended cloth comprising a fibrous mat impregnated with a firstdisinfecting solution having chlorohexidine gluconate (CHG) as an activeingredient and having no alcohol, and b. using the first impregnatedcloth to disinfect at least a portion of the patient at least one dayprior to, and up to several days prior to, the invasive procedureproximate the invasive procedure, c. providing a second blended clothcomprising a fibrous mat impregnated with a second disinfecting solutionhaving chlorohexidine gluconate (CHG) as an active ingredient and havingno alcohol, and d. using the second impregnated cloth to disinfect atleast a portion of the patient immediately prior to the invasiveprocedure proximate the invasive procedure, wherein the first blendedcloth comprises first fibers and second fibers, with the quantity byweight of said first fibers generally being greater than the quantity byweight of the second fibers, said first blended cloth having anabsorbency by weight greater than the weight of said first blendedcloth, and wherein the second blended cloth comprises first fibers andsecond fibers, with the quantity by weight of said first fibersgenerally being greater than the quantity by weight of the secondfibers, said second blended cloth having an absorbency by weight greaterthan the weight of said second blended cloth.
 12. The method accordingto claim 11, in which the first fibers of the first blended clothcomprise polyester fibers.
 13. The method according to claim 11, inwhich the second fibers of the first blended cloth comprise polyesterfibers.
 14. The method according to claim 11, in which the first fibersof the second blended cloth comprise polyester fibers.
 15. The methodaccording to claim 11, in which the second fibers of the second blendedcloth comprise polyester fibers.
 16. The method according to claim 11,wherein substantially all of the CHG in the first disinfecting solutionis released from the first blended cloth during the method step “b”. 17.The method according to claim 11, wherein substantially all of the CHGin the second disinfecting solution is released from the second blendedcloth during the method step “d”.